"The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended the marketing of selexipag (Uptravi, Actelion Registration Ltd) for the treatment of adults with pulmonary arterial hypertension (PAH)./"...
Limited data are available related to overdosage in humans. The most likely manifestation of overdosage would be hypotension. If symptomatic hypotension occurs, provide supportive treatment.
Overdosage might be expected to cause excessive peripheral vasodilation with marked hypotension and possibly a reflex tachycardia. Marked and potentially prolonged systemic hypotension up to and including shock with fatal outcome have been reported. In humans, experience with intentional overdosage of amlodipine is limited.
Single oral doses of amlodipine maleate equivalent to 40 mg amlodipine/kg and 100 mg amlodipine/kg in mice and rats, respectively, caused deaths. Single oral amlodipine maleate doses equivalent to 4 mg or more of amlodipine/kg or higher in dogs (11 or more times the MRHD on a mg/m² basis) caused a marked peripheral vasodilation and hypotension.
If massive overdose occurs, initiate active cardiac and respiratory monitoring. Frequent blood pressure measurements are essential. If hypotension occurs, provide cardiovascular support including elevation of the extremities and the judicious administration of fluids. If hypotension remains unresponsive to these conservative measures, consider administration of vasopressors (such as phenylephrine), with attention to circulating volume and urine output. As amlodipine is highly protein bound, hemodialysis is not likely to be of benefit. Administration of activated charcoal to healthy volunteers immediately or up to 2 hours after ingestion of amlodipine has been shown to significantly decrease amlodipine absorption.
The most common signs and symptoms of overdose observed in humans are those caused by electrolyte depletion (hypokalemia, hypochloremia, hyponatremia) and dehydration resulting from excessive diuresis. If digitalis has also been administered, hypokalemia may accentuate cardiac arrhythmias. The degree to which HCTZ is removed by hemodialysis has not been established. The oral LD50 of HCTZ is greater than 10 g/kg in both mice and rats. These doses are 1946 and 3892 times, respectively, the MRHD of 25 mg/day, when based on a mg/m² basis of a 60-kg individual.
Amturnide is contraindicated in patients with anuria or hypersensitivity to sulfonamide derived drugs like HCTZ or to any of the components [see WARNINGS AND PRECAUTIONS and ADVERSE REACTIONS]. Hypersensitivity reactions may range from urticaria to anaphylaxis.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 1/30/2017
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